Associate Director Enterprise IT Validation and Compliance

Associate Director Enterprise IT Validation and Compliance will provide management and thought-leadership to the IT Validation & Compliance team.

This position will be based in Durham, NC and will require a regular site presence

Job Description

• This individual will provide management and thought-leadership expertise to the IT Validation and Compliance team that consists of direct reports at a senior and principle level as well as managed validation service resources in a Contract Development and Manufacturing Organization (CDMO) setting.
• Individual will ensure that adequate resources and processes are in place to support Enterprise IT validation development, execution, review, and approval of software validation lifecycle deliverables and the validation technical oversite of change controls, CAPAs, and deviations associated with enterprise software.
• Management of relationship with managed service partner firm ensuring that contract resources are available for upcoming project and lifecycle needs.
• Work closely with partners in Quality Validation, this individual provides strategic and technical expertise for all global software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.
  
  
  

Requirements:

• 10 years experience in a cGMP environment in a computer systems validation, computerized systems quality assurance, or data integrity role with demonstrated career growth and accomplishments.
• 5 years experience managing teams and direct reports.
• Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment.
• Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as current regulatory guidance on Data Integrity.
  
  
  

Salary: 150,000 -185,000

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.